The field of the inventions generally relates to cardiovascular and closure devices, and, more particularly, to patches for placing against tissue.
In most cardiology and radiology procedures, a catheter is inserted into an artery, such as the femoral artery, through a vascular introducer. When the procedure is complete, the physician removes the catheter from the introducer and then removes the introducer from the arteriotomy into the vessel. The physician then must prevent or limit the amount of blood that leaks through the arteriotomy so that the patient can be discharged. Physicians currently use a number of methods to close the arteriotomy, such as localized compression, sutures, collagen plugs, and adhesives, gels, foams, and similar materials. To use localized compression, the physician presses down against the vessel to allow the arteriotomy to naturally clot. This method, however, can take half an hour or more, and requires the patient to remain immobilized for at least that period of time and be kept in the hospital for observation. There are potentials for clots at puncture site to be dislodged. Moreover, the amount of time necessary for the compression can be significantly increased depending upon how much heparin, glycoprotein IIb/IIA antagonists, or other anti-clotting agents were used during the procedure. Sutures and collagen plugs may have procedure variability, may require time to close the vessel, may have negative cost factors, and may necessitate a separate deployment device. Adhesives, gels, and foams may have negative cost factors, may necessitate a possibly complicated deployment process, and may have procedure variability.
In one general aspect, a patch for placing against a tissue within a mammalian includes at least one layer of a biocompatible polymer, at least one layer of a biocompatible superelastic/shape memory material, and at least one layer of a biocompatible adherent material.
Embodiments of the patch may include one or more of the following features. For example, the superelastic/shape memory material may include a nickel titanium alloy. The alloy may include Nitinol. The superelastic/shape memory material may have a curved configuration in a resting state.
The patch may further include barbs extending from the superelastic/shape memory material. The patch may further include a power source connected to the patch and configured to provide power to the barbs.
The layer of superelastic/shape memory material is encapsulated by the polymer. The patch may be intended to close an opening in the vessel. The patch may include multiple arms and a base configured to form a concave shape. One or more barbs may extend from the arms.
The patch may further include a deployment device configured to deploy the patch. The deployment device includes a handle and a deployment section with the deployment section configured to retain the patch for delivery of the patch to the vessel. The deployment section may include a pair of openable jaws and/or a surface configured to apply a vacuum.
In another general aspect, applying a patch to a tissue surface within a mammalian body includes retaining the patch to a deployment device, advancing the deployment device to the tissue surface, pressing the patch against the tissue surface, and manipulating the deployment device to separate the deployment device from the patch and leave the patch against the tissue surface. The patch includes at least one layer of a biocompatible polymer, at least one layer of a biocompatible superelastic/shape memory material, and at least one layer of a biocompatible adherent material. The deployment device includes a handle section and a deployment section, and the deployment section is configured to retain the patch for delivery of the patch to the tissue surface.
Embodiments may include one or more of the following features. For example, retaining the patch to the deployment device may include using an adhesive to retain the patch to the deployment device. Retaining the patch to the deployment device may include applying vacuum to the patch. Manipulating the deployment device to separate the deployment device from the patch may include moving the deployment device relative to the tissue surface to which the patch is applied. Manipulating the deployment device to separate the deployment device from the patch may include advancing a plunger within the deployment device. Manipulating the deployment device to separate the deployment device from the patch may include opening a pair of jaws in the deployment section.
The patch may include one or more arms, a base, and barbs extending from the arms, and advancing the deployment device to the tissue surface may include advancing the deployment device to the tissue surface of the heart.